BioBusiness

Allogene's cema-cel has received FDA RMAT and fast track designations for first-line consolidation therapy in high-risk large B-cell lymphoma.

FDA staff have questioned RP1's melanoma trial data ahead of a July 30, 2026 advisory committee vote, causing Replimune shares to fall 30%.

AbelZeta has received FDA RMAT clearance for a registrational phase 2 trial of its bispecific CAR-T therapy, C-CAR168, in refractory lupus nephritis.

GSK will invest £400 million (US$532 million) in a new Cambridge, UK, R&D center, relocating from Stevenage amid second quarter earnings and a cost-savings plan.

Brandon Pence, FUJIFILM Biosciences' president and chief operating officer, identifies cell consistency and viral vector capsid fill ratios as the 2 most critical unresolved hurdles in CGT manufacturing scale-up.

Harbour BioMed and Sinopharm have formed a strategic Innovation Consortium to co-develop biologics in oncology and immune-mediated inflammatory disease.

argenx will acquire Forte Biosciences for $2.2 billion, which will add first-in-class anti-CD122 antibody, FB102, to its immunology pipeline.

Johnson & Johnson reported that phase 3 MonumenTAL-6 data show Tecvayli plus Talvey cut the risk of progression or death by 89% in relapsed/refractory multiple myeloma.

Sanofi announced it has discontinued amlitelimab in atopic dermatitis, forgoing global regulatory submissions despite positive long-term phase 3 data.

Repligen will acquire BioLife Solutions for $1.5 billion, adding CryoStor biopreservation media to its cell therapy portfolio.

Ipsen has completed its acquisition of Memo Therapeutics, which adds potravitug, an anti-BKPyV antibody, to its rare disease pipeline.

Phase 3 SHASTA-3/4 trials show plozasiran cut triglycerides up to 81% and reduced pancreatitis events up to 100% in high-risk sHTG patients.

Propanc Biopharma has reported peer-reviewed data on scalable recombinant production of trypsinogen and chymotrypsinogen, supporting a synthetic backup to its lead cancer candidate, PRP.

Under the deal, Lonza will grant Engitix a single-target ADC license for SYNtecan E, GlycoConnect, and HydraSpace to advance ECM-targeted fibrosis and cancer therapies.

Scholar Rock’s apitegromab is awaiting a US manufacturing facility resolution, which may impact the therapy’s European review, for which clinical assessment has been completed.

Halozyme and Incyte will advance subcutaneous INCA033989 for mutCALR-positive MPNs, with the aim of improving treatment delivery while supporting targeted clinical development.

The EC has approved AbbVie's Boey (trenibotulinumtoxinE), the first serotype E neurotoxin for glabellar lines, with faster onset than current options.

At BIO 2026, Thermo Fisher Scientific's Paul Jorjorian highlighted late-stage raw material switches as being among the most disruptive and underestimated risks in biopharma development.

Boehringer Ingelheim has started a phase 2 trial of BI 3034701, an investigational triple GLP-1/GIP/NPY2 receptor agonist for obesity and overweight.

Deck Bio’s Dr Johanna K. Kaufmann spoke at BIO 2026 about how the company’s multi-peptide major histocompatibility complex T cell engager strategy aims to expand patient eligibility and overcome solid tumor heterogeneity and antigen escape resistance.

Oncolytics Biotech CEO Jared Kelly warns that investor demand for near-term tumor response data is blocking funding for trials with proven overall survival benefits.

FDA has granted priority review to obinutuzumab (Gazyva) for primary membranous nephropathy after phase 3 MAJESTY trial results showed superior remission versus tacrolimus.

Innovent Biologics and Spero Therapeutics have signed a $1.1 billion licensing deal for IBI355, a phase 2-ready Fc-silent anti-CD40L antibody planned for testing in IgG4-related disease and Sjögren's disease.

GSK reports that dostarlimab (Jemperli) monotherapy achieved sustained clinical complete responses in the phase 2 AZUR-1 trial for dMMR/MSI-H locally advanced rectal cancer, with data to be submitted for regulatory review.

As part of BioPharm International's continuing coverage from the BIO International Convention 2026, Sara Jane Demy, CEO of Demy-Colton, discusses how artificial intelligence, global collaboration, and renewed investment could help improve drug development success rates and accelerate innovation.